Swissmedic marketing authorisation number: 67280
Swissmedic marketing authorisation date: 05.11.2020


1.

Indication: Locally advanced or metastatic solid tumours with molecular alterations in relation to NTRK1/2/3, ROS1 or ALK

Phase: I

Summary: Open-label, multi-centre, single-arm, open label phase I study assessing the safety, pharmacokinetics, and efficacy of orally administered entrectinib in adult patients (aged ≥ 18) with solid tumours with molecular alterations in relation to NTRK1/2/3, ROS1 or ALK. The study comprised a dose escalation phase and a dose expansion phase.

Sponsor: F. Hoffmann-La Roche AG


2.

Indication: Locally advanced or metastatic solid tumours with NTRK1/2/3, ROS1 or ALK gene rearrangements (gene fusions)

Phase: II

Summary: Open-label, multi-centre, international, single-arm, open label phase II basket study assessing the efficacy, safety, and pharmacokinetics of oral entrectinib (600 mg once daily, administered orally) in patients with solid tumours with NTRK1/2/3, ROS1 or ALK gene rearrangements (gene fusions).

Sponsor: F. Hoffmann-La Roche AG


3.

Indication: Locally advanced or metastatic solid tumours with NTRK1/2/3, ROS1 or ALK gene rearrangements (gene fusions)

Phase: I/II

Summary: Open-label, multi-centre, single-arm, phase I-II dose escalation study assessing the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D), as well as the safety, pharmacokinetics, and efficacy, of entrectinib administered orally once daily in paediatric patients with recurrent or refractory extracranial solid tumours (phase I). The safety, pharmacokinetics, and efficacy of the RP2D for entrectinib administered orally once daily are assessed in the additional expansion cohorts (phase II) in paediatric patients with primary brain tumours and extracranial solid tumours, which exhibit NTRK1/2/3 or ROS1 gene fusions.

Sponsor: F. Hoffmann-La Roche AG


4.

Indication: Locally advanced or metastatic solid tumours with molecular alterations in NTRK1/2/3, ROS1 or ALK

Phase: I

Summary: Open-label, single-arm, open label phase I study to determine the maximum tolerated dose (MTD) in patients aged ≥ 18 with solid tumours with molecular alterations in NTRK1/2/3, ROS1 or ALK.

Sponsor: F. Hoffmann-La Roche AG

References:

  1. Drillon et al., Lancet Oncology, 2020 Feb;21(2):261-270

  2. Doebele et al., Lancet Oncology, 2020 Feb;21(2):271-282

  3. Drillon et al., Lancet Oncology, 2020 Feb;21(2):261-270

  4. Doebele et al., Lancet Oncology, 2020 Feb;21(2):271-282

  5. Drillon et al., Lancet Oncology, 2020 Feb;21(2):261-270

  6. Doebele et al., Lancet Oncology, 2020 Feb;21(2):271-282

Publication of the results of clinical trials


The information given above and the links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorisation for Rozlytrek. Articles 71-73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorisation by Swissmedic. The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.

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